Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Packaging, product label and leaflets (PILs)

BioVentures Consulting Limited can provide assistance with the interpretation of EU guidance for packaging, the product label and patient information leaflet (PIL). This may include excipient and readability guideline interpretation, best practice guidance on labelling (including small containers and blister foils). We can help with explaining changes in label and leaflet legislation, including Braille and user testing. BioVentures Consulting Limited expertise will ensure information for leaflet requirements such as:

  • What the medicine is for
  • Information necessary before taking the product
  • How to take the product
  • Ensuring side effects and safe storage have been properly considered and communicated
  • product information such as active ingredients, excipients, pack size(s), the marketing authorisation holder and manufacturer, and the date of the revision of the text.

This is a highly important document in which the many thousands of pages of text and data accumulated in over a decade of development is synthesised down to just a few pages aimed at the lay person and patient end-user

BioVentures Consulting Limited can compile the leaflet summary. This is a highly important document in which the many thousands of pages of text and data accumulated in over a decade of development is synthesised down to just a few pages aimed at the lay person and patient end-user. We will ensure information for this mandatory document is presented in the correct specified order, consistent with the SmPC in non-promotional, lay language.

There is no substitute for reading the label

BioVentures Consulting Limited will ensure the technical leaflets comply with the requirements of Directive 2001/83/EC (as amended), including:

  • The product name (followed by 3 common names)
  • A statement of active content and excipients of known effect
  • The pack contents such as weight, volume and doses
  • The method and route of administration
  • Storage requirements
  • Precautions and special warnings relevant to the safe use of the product
  • Disposal instructions
  • The marketing authorisation holder name and address
  • Product licence number, the batch number and expiry date.

For clients with blister foils BioVentures Consulting Limited will ensure that, due to the lack of space, Directive of Article 55.2 will be followed, and Article 55.3 for clients with products in small containers, with a nominal volume of ≤ 10ml. BioVentures Consulting Limited will address the Excipient guidelines where it applies to injectable, topical, eye preparation and inhaled medicines; and excipients declared in the leaflet including constituents of the capsule shell, film coat, polish and printing inks, pH adjusters, diluents and preservatives.

In so many ways medicines labelling can be improved

BioVentures Consulting Limited can also assess our client’s packaging and labelling to ensure comply with the readability guidelines so that information presented is accessible and can be easily understood by patients, including making specific recommendations for blind and partially sighted patients; and design the test method for the user testing programme. BioVentures Consulting Limited recognises there is no substitute for reading the label and that certain information is critical for the safe use of the product. Presentation is important. We recognise that similarity in packaging with other products and look alike/sound alike can cause problems. In so many ways medicines labelling can be improved. BioVentures Consulting Limited can assess out clients needs whilst not losing focus on the critical information of the drug name, strength, route of administration, dosage and warnings.

For more information contact us on: This email address is being protected from spambots. You need JavaScript enabled to view it.

Go to top